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Completed

NCT Number: NCT02984111

Erythropoietin Effect on Ischemic_ Reperfusion Injury in Coronary Artery Bypass Graft Surgery

The aim of this trail is to assess the safety and therapeutic effects of single EPO intervention in different times during coronary surgery in changes of inflammatory response.

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Key information

Conditions

Myocardial Ischemic Reperfusion Injury Cardiomyopathies Cardiovascular Diseases Heart Diseases Inflammation Myocardial Ischemia Myocardial Reperfusion Injury Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Reperfusion Injury Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cardiovascular Research Center, Shahid Beheshti University of Medical Sciences.

Tehran, 199873438, Iran

About this study

In addition to well-known effect of Erythropoietin (EPO) on erythropoiesis in hypoxic conditions, some lines of evidence suggest its protective effects against reperfusion injury in several tissues by its specific receptor.

Preclinical studies have indicated a broad variety of cardioprotective actions for EPO. It improves cardiac function and exercise capacity in congestive heart failure, angiogenesis, limit myocardial inflammatory response, cardiac remodeling, infarct size and apoptosis extension induced by reperfusion injury. Activation of EPO receptor in endothelial and cardiac cells is suggested to attenuate proinflammatory cytokines production and inflammatory cells infiltration, and increasing nitric oxide production through possible mechanisms.

Reperfusion injury is unavoidable event during cardiac surgery using cardiopulmonary bypass.It is associated with inflammation, cell injury and attenuate contractility property.

Although it is an area of concern and many clinical studies have been designed by different interventions, it remains a major challenge. EPO intervention during heart reperfusion (surgery/ percutaneous angioplasty) as a new promise of cardioprotection strategy is the main design of several studies with conflicting results .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Revascularization requirement according to angiographic evidence
  • Elective coronary artery bypass graft surgery
  • First time coronary artery bypass graft surgery
  • On-pump coronary artery bypass graft surgery

Exclusion criteria

  • History of myocardial infarction in the past 3 months
  • Previous myocardial trauma or major surgery in the past 3 months
  • Cr>2mg/dl
  • Receiving streptokinase or previous reperfusion treatments
  • Erythropoietin intake in the recent 6 months
  • Known thromboembolic disorder and malignant disease
  • Uncontrolled hypertension
  • Polycythemia
  • Previous valvular surgery

Treatment and study plan

normal saline

Drug

Other names: N/S

Erythropoietin

Drug

Other names: epoietin alfa

Primary outcomes

  1. Change in Interleukin 6(IL6)

    Time frame: Change from baseline until 48 hours after surgery

    Serum IL6(an inflammatory marker) level is measured before operation (base),just after operation,24 hours after operation,48 hours after operation

  2. Change in YKL-40

    Time frame: Change from baseline until 48 hours after surgery

    Chitinase-3-like protein 1 (CHI3L1), also known as YKL-40 is an inflammatory marker.Serum YKL-40 level is measured before operation (base),just after operation,24 hours after operation,48 hours after operation

  3. Change in pro b-type natriuretic peptide(pro BNP)

    Time frame: Change from baseline until 48 hours after surgery

    Serum pro BNP level is measured before operation (base),just after operation,24 hours after operation,48 hours after operation

Secondary outcomes

  1. Volume of bleeding

    Time frame: During operation until 24 hours after surgery

  2. Need to blood transfusion

    Time frame: During and after operation, through study completion,an average of one week

    Number of packed cell and fresh frozen plasma that transfused in the period of time that patient is hospitalized.

  3. Ventilation time

    Time frame: Period of time after surgery that patient has been intubated in ICU,an average of 10 hours

Sponsors and collaborators

Lead sponsor

Shahid Beheshti University of Medical Sciences

Other

Collaborators

  • Pooyesh Darou

Registry information

Official study title

Placebo- Controlled,Randomized,Double Blind Trial of Erythropoietin Effect on Ischemic_ Reperfusion Injury in Coronary Artery Bypass Graft Surgery

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 6, 2016
Registry last updated
Oct 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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